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disCOVEries: A Study to Determine Antibody Levels After Receiving COVID-19 Boosters of Any Kind

Sponsor
ModernaTX, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05367908
Collaborator
(none)
1,501
Enrollment
1
Location
5.7
Anticipated Duration (Months)
265.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate antibody levels with respect to time since receiving a COVID-19 booster shot. The study will be decentralized, where participants can complete all study tasks at home. Self-reported participant information will be collected via surveys conducted at intake and monthly throughout the study. Participants will also perform monthly at-home capillary blood draws via YourBio devices that will be mailed to the designated laboratory for sample processing and antibody testing.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1501 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Discoveries - Different Immunization Boosters for Covid-19: Effect on Response in Antibodies
    Actual Study Start Date :
    Apr 11, 2022
    Anticipated Primary Completion Date :
    Aug 31, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort 1: MMM (Moderna Vaccine Series)

    Participants who have only received Moderna COVID-19 vaccines (that is, the 2-shot series and a booster).
    Cohort 2: PPP (Pfizer Vaccine Series)

    Participants who have only received Pfizer COVID-19 vaccines (that is, the 2-shot series and a booster).
    Cohort 3: V (Other Combination of Vaccines)

    Participants who have received any other combinations of boosters authorized in the United States, such as the 2-shot Pfizer series and a Moderna booster (PPM), the 2-shot Moderna series and a Pfizer booster (MMP), or the 1-shot Johnson and Johnson vaccine with either a Moderna or Pfizer booster.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Antibody Levels Since Receiving a COVID-19 Booster Vaccine at 0, 1, and 2 Months Post Enrollment [Baseline (Month 0), Month 1, and Month 2]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Lives in the continental United States.

    • Has been vaccinated against COVID-19 with a U.S.-authorized vaccine (that is, received the single shot J&J vaccine or both shots in the Pfizer or Moderna series).

    • Has received a COVID-19 booster between September 2021 and screening.

    • Is willing and able to submit vaccination card photo(s).

    • Is willing and able to self-collect capillary blood 3 times during the study period via an at-home whole-blood collection device (that is, the YourBio TAP II Device).

    Exclusion Criteria:

    • Has been diagnosed with significant cognitive impairment or dementia.

    • Has received more than one COVID-19 vaccine booster at screening.

    • Is currently participating in a COVID-19 vaccine clinical trial.

    • Is currently receiving chemotherapy or has received chemotherapy in the past 6 months.

    • Is currently taking steroids, such as prednisone, for any condition.

    • Has been diagnosed with or is taking medications for rheumatoid arthritis (RA), lupus or multiple sclerosis (MS).

    • Has received an organ transplant

    • Is currently undergoing dialysis of any kind (for example, hemodialysis or chronic ambulatory dialysis) for kidney disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Evidation Health San Mateo California United States 94402

    Sponsors and Collaborators

    • ModernaTX, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ModernaTX, Inc.
    ClinicalTrials.gov Identifier:
    NCT05367908
    Other Study ID Numbers:
    • mRNA-1273-P914
    First Posted:
    May 10, 2022
    Last Update Posted:
    Jun 16, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 16, 2022